Something is wrong
when regulatory agencies pretend that vitamins are dangerous, yet
ignore published statistics showing that government-sanctioned
medicine is the real hazard.

Until now, Life
Extension could cite only isolated statistics to make its case about
the dangers of conventional medicine. No one had ever analyzed and
combined ALL of the published literature dealing with injuries and
deaths caused by government-protected medicine. That has now changed.

A group of
researchers meticulously reviewed the statistical evidence and their
findings are absolutely shocking.4
These researchers have authored a paper titled “Death by Medicine”
that presents compelling evidence that today’s system frequently
causes more harm than good.

This fully
referenced report shows the number of people having in-hospital,
adverse reactions to prescribed drugs to be 2.2 million per year. The
number of unnecessary antibiotics prescribed annually for viral
infections is 20 million per year. The number of unnecessary medical
and surgical procedures performed annually is 7.5 million per year.
The number of people exposed to unnecessary hospitalization annually
is 8.9 million per year.

The most stunning
statistic, however, is that the total number of deaths caused by
conventional medicine is an astounding 783,936 per year. It is now
evident that the American medical system is the leading cause of death
and injury in the US. (By contrast, the number of deaths attributable
to heart disease in 2001 was 699,697, while the number of deaths
attributable to cancer was 553,251.5)

We placed this
article on our website to memorialize the failure of the American
medical system. By exposing these gruesome statistics in painstaking
detail, we provide a basis for competent and compassionate medical
professionals to recognize the inadequacies of today’s system and at
least attempt to institute meaningful reforms.

Natural
medicine is under siege, as pharmaceutical company lobbyists urge
lawmakers to deprive Americans of the benefits of dietary supplements.
Drug-company front groups have launched slanderous media campaigns to
discredit the value of healthy lifestyles. The FDA continues to
interfere with those who offer natural products that compete with
prescription drugs.

These attacks
against natural medicine obscure a lethal problem that until now was
buried in thousands of pages of scientific text. In response to these
baseless challenges to natural medicine, the Nutrition Institute of
America commissioned an independent review of the quality of
“government-approved” medicine. The startling findings from this
meticulous study indicate that conventional medicine is “the leading
cause of death” in the United States .

The Nutrition
Institute of America is a nonprofit organization that has sponsored
independent research for the past 30 years. To support its bold claim
that conventional medicine is America 's number-one killer, the
Nutritional Institute of America mandated that every “count” in this
“indictment” of US medicine be validated by published, peer-reviewed
scientific studies.

What you are
about to read is a stunning compilation of facts that documents that
those who seek to abolish consumer access to natural therapies are
misleading the public. Over 700,000 Americans die each year at the
hands of government-sanctioned medicine, while the FDA and other
government agencies pretend to protect the public by harassing those
who offer safe alternatives.

A definitive
review of medical peer-reviewed journals and government health
statistics shows that American medicine frequently causes more harm
than good.

Each year
approximately 2.2 million US hospital patients experience adverse drug
reactions (ADRs) to prescribed medications.(1)
In 1995, Dr. Richard Besser of the federal Centers for Disease Control
and Prevention (CDC) estimated the number of unnecessary antibiotics
prescribed annually for viral infections to be 20 million; in 2003,
Dr. Besser spoke in terms of tens of millions of unnecessary
antibiotics prescribed annually.(2,
2a) Approximately 7.5 million
unnecessary medical and surgical procedures are performed annually in
the US,(3)
while approximately 8.9 million Americans are hospitalized
unnecessarily.(4)

As shown in the
following table, the estimated total number of iatrogenic deaths—that
is, deaths induced inadvertently by a physician or surgeon or by
medical treatment or diagnostic procedures— in the US annually is
783,936. It is evident that the American medical system is itself the
leading cause of death and injury in the US . By comparison,
approximately 699,697 Americans died of heart in 2001, while 553,251
died of cancer.(5)

Using Leape's 1997
medical and drug error rate of 3 million(14)
multiplied by the 14% fatality rate he used in 1994(16)
produces an annual death rate of 420,000 for drug errors and medical
errors combined. Using this number instead of Lazorou's 106,000 drug
errors and the Institute of Medicine 's (IOM) estimated 98,000 annual medical errors would add another
216,000 deaths, for a total of 999,936 deaths annually.

The enumerating of
unnecessary medical events is very important in our analysis. Any
invasive, unnecessary medical procedure must be considered as part of
the larger iatrogenic picture. Unfortunately, cause and effect go
unmonitored. The figures on unnecessary events represent people who
are thrust into a dangerous health care system. Each of these 16.4
million lives is being affected in ways that could have fatal
consequences. Simply entering a hospital could result in the
following:

In 16.4 million
people, a 2.1% chance (affecting 186,000) of a serious adverse drug
reaction(1)

In 16.4 million
people, a 5-6% chance (affecting 489,500) of acquiring a nosocomial
infection(9)

In16.4 million
people, a 4-36% chance (affecting 1.78 million) of having an
iatrogenic injury (medical error and adverse drug reactions).(16)

In 16.4 million
people, a 17% chance (affecting 1.3 million) of a procedure error.(40)

These statistics
represent a one-year time span. Working with the most conservative
figures from our statistics, we project the following 10-year death
rates.

Table 3:
Estimated 10-Year Death Rates from Medical Intervention

Condition

10-Year Deaths

Author

Adverse Drug
Reaction

1.06 million

(1)

Medical error

0.98 million

(6)

Bedsores

1.15 million

(7,8)

Nosocomial
Infection

0.88 million

(9,10)

Malnutrition

1.09 million

(11)

Outpatients

1.99 million

(12, 112)

Unnecessary
Procedures

371,360

(3,13)

Surgery-related

320,000

(85)

Total

7,841,360

Our estimated
10-year total of 7.8 million iatrogenic deaths is more than all the
casualties from all the wars fought by the US throughout its entire
history.

Our projected
figures for unnecessary medical events occurring over a 10-year period
also are dramatic.

Table 4:
Estimated 10-Year Unnecessary Medical Events

Unnecessary
Events

10-year Number

Iatrogenic
Events

Hospitalization

89 million(4)

17 million

Procedures

75 million(3)

15 million

Total

164 million

These figures show
that an estimated 164 million people—more than half of the total US
population—receive unneeded medical treatment over the course of a
decade.

INTRODUCTION

Never before have
the complete statistics on the multiple causes of iatrogenesis been
combined in one article. Medical science amasses tens of thousands of
papers annually, each representing a tiny fragment of the whole
picture. To look at only one piece and try to understand the benefits
and risks is like standing an inch away from an elephant and trying to
describe everything about it. You have to step back to see the big
picture, as we have done here. Each specialty, each division of
medicine keeps its own records and data on morbidity and mortality. We
have now completed the painstaking work of reviewing thousands of
studies and putting pieces of the puzzle together.

Is American Medicine Working?

US health care
spending reached $1.6 trillion in 2003, representing 14% of the
nation's gross national product.(15)
Considering this enormous expenditure, we should have the best
medicine in the world. We should be preventing and reversing disease,
and doing minimal harm. Careful and objective review, however, shows
we are doing the opposite. Because of the extraordinarily narrow,
technologically driven context in which contemporary medicine examines
the human condition, we are completely missing the larger picture.

Medicine is not
taking into consideration the following critically important aspects
of a healthy human organism: (a)
stress and how it adversely affects the immune system and life
processes; (b)
insufficient exercise; (c)
excessive caloric intake; (d)
highly processed and denatured foods grown in denatured and chemically
damaged soil; and (e)
exposure to tens of thousands of environmental toxins. Instead of
minimizing these disease-causing factors, we cause more illness
through medical technology, diagnostic testing, overuse of medical and
surgical procedures, and overuse of pharmaceutical drugs. The huge
disservice of this therapeutic strategy is the result of little effort
or money being spent on preventing disease.

Underreporting of Iatrogenic Events

As few as 5% and
no more than 20% of iatrogenic acts are ever reported.(16,24,25,33,34)
This implies that if medical errors were completely and accurately
reported, we would have an annual iatrogenic death toll much higher
than 783,936. In 1994, Leape said his figure of 180,000 medical
mistakes resulting in death annually was equivalent to three jumbo-jet
crashes every two days.(16)
Our considerably higher figure is equivalent to six jumbo jets are
falling out of the sky each day.

What we must
deduce from this report is that medicine is in need of complete and
total reform—from the curriculum in medical schools to protecting
patients from excessive medical intervention. It is obvious that we
cannot change anything if we are not honest about what needs to be
changed. This report simply shows the degree to which change is
required.

We are fully aware
of what stands in the way of change: powerful pharmaceutical and
medical technology companies, along with other powerful groups with
enormous vested interests in the business of medicine. They fund
medical research, support medical schools and hospitals, and advertise
in medical journals. With deep pockets, they entice scientists and
academics to support their efforts. Such funding can sway the balance
of opinion from professional caution to uncritical acceptance of new
therapies and drugs. You have only to look at the people who make up
the hospital, medical, and government health advisory boards to see
conflicts of interest. The public is mostly unaware of these
interlocking interests.

For example, a
2003 study found that nearly half of medical school faculty who serve
on institutional review boards(IRB)
to advise on clinical trial research also serve as consultants to the
pharmaceutical industry.(17)
The study authors were concerned that such representation could cause
potential conflicts of interest. A news release by Dr. Erik Campbell,
the lead author, said, "Our previous research with faculty has shown
us that ties to industry can affect scientific behavior, leading to
such things as trade secrecy and delays in publishing research. It's
possible that similar relationships with companies could affect IRB
members' activities and attitudes.”(18)

Medical Ethics and Conflict of Interest in
Scientific Medicine

Jonathan Quick,
director of essential drugs and medicines policy for the World Health
Organization (WHO), wrote in a recent WHO bulletin: "If clinical
trials become a commercial venture in which self-interest overrules
public interest and desire overrules science, then the social contract
which allows research on human subjects in return for medical advances
is broken."(19)

As former editor
of the New England Journal of Medicine , Dr. Marcia Angell
struggled to bring greater attention to the problem of commercializing
scientific research. In her outgoing editorial entitled “ Is Academic
Medicine for Sale?” Angell said that growing conflicts of interest are
tainting science and called for stronger restrictions on
pharmaceutical stock ownership and other financial incentives for
researchers:(20)
“When the boundaries between industry and academic medicine become as
blurred as they are now, the business goals of industry influence the
mission of medical schools in multiple ways.” She did not discount the
benefits of research but said a Faustian bargain now existed between
medical schools and the pharmaceutical industry.

Angell left the
New England Journal in June 2000. In June 2002, the New England
Journal of Medicine announced that it would accept journalists who
accept money from drug companies because it was too difficult to find
ones who have no ties. Another former editor of the journal, Dr.
Jerome Kassirer, said that was not the case and that plenty of
researchers are available who do not work for drug companies.(21)
According to an ABC news report, pharmaceutical companies spend over
$2 billion a year on over 314,000 events attended by doctors.

The ABC news
report also noted that a survey of clinical trials revealed that when
a drug company funds a study, there is a 90% chance that the drug will
be perceived as effective whereas a non-drug-company-funded study will
show favorable results only 50% of the time. It appears that money
can't buy you love but it can buy any "scientific" result desired.

Cynthia Crossen, a
staffer for the Wall Street Journal, i n 1996 published Tainted
Truth : The Manipulation of Fact in America , a book about
the widespread practice of lying with statistics.(22)
Commenting on the state of scientific research, she wrote: “The road
to hell was paved with the flood of corporate research dollars that
eagerly filled gaps left by slashed government research funding.” Her
data on financial involvement showed that in l981 the drug industry
“gave” $292 million to colleges and universities for research. By
l991, this figure had risen to $2.1 billion.

THE FIRST
IATROGENIC STUDY

Dr. Lucian L.
Leape opened medicine's Pandora's box in his 1994 paper, “Error in
Medicine,” which appeared in the Journal of the American Medical
Association (JAMA).(16)
He found that Schimmel reported in 1964 that 20% of hospital patients
suffered iatrogenic injury, with a 20% fatality rate. In 1981 Steel
reported that 36% of hospitalized patients experienced iatrogenesis
with a 25% fatality rate, and adverse drug reactions were involved in
50% of the injuries. In 1991, Bedell reported that 64% of acute heart
attacks in one hospital were preventable and were mostly due to
adverse drug reactions.

Leape focused on
the “Harvard Medical Practice Study” published in 1991, (16a)
which found a 4% iatrogenic injury rate for patients, with a 14%
fatality rate, in 1984 in New York State. From the 98,609 patients
injured and the 14% fatality rate, he estimated that in the entire
U.S. 180,000 people die each year partly as a result of iatrogenic
injury.

Why Leape chose to
use the much lower figure of 4% injury for his analysis remains in
question. Using instead the average of the rates found in the three
studies he cites (36%, 20%, and
4%) would have produced a 20% medical error rate. The number of iatrogenic
deaths using an average rate of injury and his 14% fatality rate would
be 1,189,576.

Leape acknowledged
that the literature on medical errors is sparse and represents only
the tip of the iceberg, noting that when errors are specifically
sought out, reported rates are “distressingly high.” He cited several
autopsy studies with rates as high as 35-40% of missed diagnoses
causing death. He also noted that an intensive care unit reported an
average of 1.7 errors per day per patient, and 29% of those errors
were potentially serious or fatal.

Leape calculated
the error rate in the intensive care unit study. First, he found that
each patient had an average of 178 “activities”
(staff/procedure/medical interactions) a day, of which 1.7 were
errors, which means a 1% failure rate. This may not seem like much,
but Leape cited industry standards showing that in aviation, a 0.1%
failure rate would mean two unsafe plane landings per day at Chicago's
O'Hare International Airport; in the US Postal Service, a 0.1% failure
rate would mean 16,000 pieces of lost mail every hour; and in the
banking industry, a 0.1% failure rate would mean 32,000 bank checks
deducted from the wrong bank account.

In trying to
determine why there are so many medical errors, Leape acknowledged the
lack of reporting of medical errors. Medical errors occur in thousands
of different locations and are perceived as isolated and unusual
events. But the most important reason that the problem of medical
errors is unrecognized and growing, according to Leape, is that
doctors and nurses are unequipped to deal with human error because of
the culture of medical training and practice. Doctors are taught that
mistakes are unacceptable. Medical mistakes are therefore viewed as a
failure of character and any error equals negligence. No one is taught
what to do when medical errors do occur. Leape cites McIntyre and
Popper, who said the “infallibility model” of medicine leads to
intellectual dishonesty with a need to cover up mistakes rather than
admit them. There are no Grand Rounds on medical errors, no sharing of
failures among doctors, and no one to support them emotionally when
their error harms a patient.

Leape hoped his
paper would encourage medical practitioners “to fundamentally change
the way they think about errors and why they occur.” It has been
almost a decade since this groundbreaking work, but the mistakes
continue to soar.

In 1995, a JAMA
report noted, "Over a million patients are injured in US hospitals
each year, and approximately 280,000 die annually as a result of these
injuries. Therefore, the iatrogenic death rate dwarfs the annual
automobile accident mortality rate of 45,000 and accounts for more
deaths than all other accidents combined."(23)

At a 1997 press
conference, Leape released a nationwide poll on patient iatrogenesis
conducted by the National Patient Safety Foundation (NPSF), which is
sponsored by the American Medical Association (AMA).
Leape is a founding member of NPSF. The survey found that more than
100 million Americans have been affected directly or indirectly by a
medical mistake. Forty-two percent were affected directly and 84%
personally knew of someone who had experienced a medical mistake.(14)

At this press
conference, Leape updated his 1994 statistics, noting that as of 1997,
medical errors in inpatient hospital settings nationwide could be as
high as 3 million and could cost as much as $200 billion . Leape used
a 14% fatality rate to determine a medical error death rate of 180,000
in 1994.(16)
In 1997, using Leape's base number of 3 million errors, the annual
death rate could be as high as 420,000 for hospital inpatients alone.

ONLY A FRACTION
OF MEDICAL ERRORS ARE REPORTED

In 1994, Leape
said he was well aware that medical errors were not being reported.(16)
A study conducted in two obstetrical units in the UK found that only
about one-quarter of adverse incidents were ever reported, to protect
staff, preserve reputations, or for fear of reprisals, including
lawsuits.(24).
An analysis by Wald and Shojania found that only 1.5% of all adverse
events result in an incident report, and only 6% of adverse drug
events are identified properly. The authors learned that the American
College of Surgeons estimates that surgical incident reports routinely
capture only 5-30% of adverse events. In one study, only 20% of
surgical complications resulted in discussion at morbidity and
mortality rounds.(25)
From these studies, it appears that all the statistics gathered on
medical errors may substantially underestimate the number of adverse
drug and medical therapy incidents. They also suggest that our
statistics concerning mortality resulting from medical errors may be
in fact be conservative figures.

An article in
Psychiatric Times (April 2000) outlines the stakes involved in
reporting medical errors.(26)
The authors found that the public is fearful of suffering a fatal
medical error, and doctors are afraid they will be sued if they report
an error. This brings up the obvious question: who is reporting
medical errors? Usually it is the patient or the patient's surviving
family. If no one notices the error, it is never reported. Janet
Heinrich, an associate director at the U.S. General Accounting Office
responsible for health financing and public health issues, testified
before a House subcommittee hearing on medical errors that "the full
magnitude of their threat to the American public is unknown” and
"gathering valid and useful information about adverse events is
extremely difficult." She acknowledged that the fear of being blamed,
and the potential for legal liability, played key roles in the
underreporting of errors. The Psychiatric Times noted that the
AMA strongly opposes mandatory reporting of medical errors.(26)
If doctors are not reporting, what about nurses? A survey of nurses
found that they also fail to report medical mistakes for fear of
retaliation.(27)

Standard medical
pharmacology texts admit that relatively few doctors ever report
adverse drug reactions to the FDA.(28)
The reasons range from not knowing such a reporting system exists to
fear of being sued.(29)
Yet the public depends on this tremendously flawed system of voluntary
reporting by doctors to know whether a drug or a medical intervention
is harmful.

Pharmacology texts
also will tell doctors how hard it is to separate drug side effects
from disease symptoms. Treatment failure is most often attributed to
the disease and not the drug or doctor. Doctors are warned, “Probably
nowhere else in professional life are mistakes so easily hidden, even
from ourselves.”(30)
It may be hard to accept, but it is not difficult to understand why
only 1 in 20 side effects is reported to either hospital
administrators or the FDA.(31,
31a)

If hospitals
admitted to the actual number of errors for which they are
responsible, which is about 20 times what is reported, they would come
under intense scrutiny.(32)
Jerry Phillips, associate director of the FDA's Office of Post
Marketing Drug Risk Assessment, confirms this number. “In the broader
area of adverse drug reaction data, the 250,000 reports received
annually probably represent only 5% of the actual reactions that
occur.”(33)
Dr. Jay Cohen, who has extensively researched adverse drug reactions,
notes that because only 5% of adverse drug reactions are reported,
there are in fact 5 million medication reactions each year.(34)

A 2003 survey is
all the more distressing because there seems to be no improvement in
error reporting, even with all the attention given to this topic. Dr.
Dorothea Wild surveyed medical residents at a community hospital inConnecticut and found that only half were aware that the hospital had a medical
error-reporting system, and that the vast majority did not use it at
all. Dr. Wild says this does not bode well for the future. If doctors
don't learn error reporting in their training, they will never use it.
Wild adds that error reporting is the first step in locating the gaps
in the medical system and fixing them. Not even that first step has
been taken to date.(35)

PUBLIC
SUGGESTIONS ON IATROGENESIS

In a telephone
survey, 1,207 adults ranked the effectiveness of the following
measures in reducing preventable medical errors that result in serious
harm.(36)
(Following each measure is the percentage of respondents who ranked
the measure as “very effective.”)

requiring
hospitals to report all serious medical errors to a state agency
(71%)

increasing the
number of hospital nurses (69%)

reducing the
work hours of doctors in training to avoid fatigue (66%)

encouraging
hospitals to voluntarily report serious medical errors to a state
agency (62%).

DRUG
IATROGENESIS

Prescription drugs
constitute the major treatment modality of scientific medicine. With
the discovery of the “germ theory,” medical scientists convinced the
public that infectious organisms were the cause of illness. Finding
the “cure” for these infections proved much harder than anyone
imagined. From the beginning, chemical drugs promised much more than
they delivered. But far beyond not working, the drugs also caused
incalculable side effects. The drugs themselves, even when properly
prescribed, have side effects that can be fatal, as Lazarou's study(1)
showed. But human error can make the situation even worse.

Medication
Errors

A survey of a 1992
national pharmacy database found a total of 429,827 medication errors
from 1,081 hospitals. Medication errors occurred in 5.22% of patients
admitted to these hospitals each year. The authors concluded that at
least 90,895 patients annually were harmed by medication errors in the
US as a whole.(37)

A 2002 study shows
that 20% of hospital medications for patients had dosage errors.
Nearly 40% of these errors were considered potentially harmful to the
patient. In a typical 300-patient hospital, the number of errors per
day was 40.(38)

Problems involving
patients' medications were even higher the following year. The error
rate intercepted by pharmacists in this study was 24%, making the
potential minimum number of patients harmed by prescription drugs
417,908.(39)

Recent Adverse Drug Reactions

More-recent
studies on adverse drug reactions show that the figures from 1994
published in Lazarou's 1998 JAMA article may be increasing. A
2003 study followed 400 patients after discharge from a tertiary care
hospital setting (requiring highly specialized skills, technology, or
support services). Seventy-six patients (19%) had adverse events.
Adverse drug events were the most common, at 66% of all events. The
next most common event was procedure-related injuries, at 17%.(40)

In a New
England Journal of Medicine study, an alarming one in four
patients suffered observable side effects from the more than 3.34
billion prescription drugs filled in 2002.(41)
One of the doctors who produced the study was interviewed by Reuters
and commented, "With these 10-minute appointments, it's hard for the
doctor to get into whether the symptoms are bothering the patients."(42)
William Tierney, who editorialized on the New England Journal
study, said “… given the increasing number of powerful drugs available
to care for the aging population, the problem will only get worse.”
The drugs with the worst record of side effects were selective
serotonin reuptake inhibitors ( SSRIs), nonsteroidal anti-inflammatory
drugs (NSAIDs), and calcium-channel blockers. Reuters also reported
that prior research has suggested that nearly 5% of hospital
admissions (over 1 million per year) are the result of drug side
effects. But most of the cases are not documented as such. The study
found that one of the reasons for this failure is that in nearly
two-thirds of the cases, doctors could not diagnose drug side effects
or the side effects persisted because the doctor failed to heed the
warning signs.

Medicating Our Feelings

Patients seeking a
more joyful existence and relief from worry, stress, and anxiety often
fall victim to the messages endlessly displayed on TV and billboards.
Often, instead of gaining relief, they fall victim to the myriad
iatrogenic side effects of antidepressant medication.

Moreover, a whole
generation of antidepressant users has been created from young people
growing up on Ritalin. Medicating youth and modifying their emotions
must have some impact on how they learn to deal with their feelings.
They learn to equate coping with drugs rather than with their inner
resources. As adults, these medicated youth reach for alcohol, drugs,
or even street drugs to cope. According to JAMA , “Ritalin acts
much like cocaine.”(43)
Today's marketing of mood-modifying drugs such as Prozac and Zoloft ®
makes them not only socially acceptable but almost a necessity in
today's stressful world.

Television Diagnosis

To reach the
widest audience possible, drug companies are no longer just targeting
medical doctors with their marketing of antidepressants. By 1995, drug
companies had tripled the amount of money allotted to direct
advertising of prescription drugs to consumers. The majority of this
money is spent on seductive television ads. From 1996 to 2000,
spending rose from $791 million to nearly $2.5 billion.(44)
This $2.5 billion represents only 15% of the total pharmaceutical
advertising budget. While the drug companies maintain that
direct-to-consumer advertising is educational, Dr. Sidney M. Wolfe of
the Public Citizen Health Research Group in Washington, DC, argues
that the public often is misinformed about these ads.(45)
People want what they see on television and are told to go to their
doctors for a prescription. Doctors in private practice either
acquiesce to their patients' demands for these drugs or spend valuable
time trying to talk patients out of unnecessary drugs. Dr. Wolfe
remarks that one important study found that people mistakenly believe
that the “FDA reviews all ads before they are released and allows only
the safest and most effective drugs to be promoted directly to the
public.”(46)

How Do We Know
Drugs Are Safe?

Another aspect of
scientific medicine that the public takes for granted is the testing
of new drugs. Drugs generally are tested on individuals who are fairly
healthy and not on other medications that could interfere with
findings. But when these new drugs are declared “safe” and enter the
drug prescription books, they are naturally going to be used by people
who are on a variety of other medications and have a lot of other
health problems. Then a new phase of drug testing called
“post-approval” comes into play, which is the documentation of side
effects once drugs hit the market. In one very telling report, the
federal government's General Accounting Office "found that of the 198
drugs approved by the FDA between 1976 and 1985... 102 (or 51.5%) had
serious post-approval risks... the serious post-approval risks
(included) heart failure, myocardial infarction, anaphylaxis,
respiratory depression and arrest, seizures, kidney and liver failure,
severe blood disorders, birth defects and fetal toxicity, and
blindness."(47)

NBC Television's
investigative show “Dateline” wondered if your doctor is moonlighting
as a drug company representative. After a yearlong investigation, NBC
reported that because doctors can legally prescribe any drug to any
patient for any condition, drug companies heavily promote "off label"
and frequently inappropriate and untested uses of these medications,
even though these drugs are approved only for the specific indications
for which they have been tested.(48)

The leading causes
of adverse drug reactions are antibiotics(17%),
cardiovascular drugs (17%),
chemotherapy (15%),
and analgesics and anti-inflammatory agents (15%).(49)

Specific Drug
Iatrogenesis: Antibiotics

According to
William Agger, MD, director of microbiology and chief of infectious
disease at Gundersen Lutheran Medical Center in La Crosse, WI, 30
million pounds of antibiotics are used in America each year.(50)
Of this amount, 25 million pounds are used in animal husbandry, and 23
million pounds are used to try to prevent disease and the stress of
shipping, as well as to promote growth. Only 2 million pounds are
given for specific animal infections. Dr. Agger reminds us that low
concentrations of antibiotics are measurable in many of our foods and
in various waterways around the world, much of it seeping in from
animal farms.

Agger contends
that overuse of antibiotics results in food-borne infections resistant
to antibiotics. Salmonella is found in 20% of ground meat, but the
constant exposure of cattle to antibiotics has made 84% of salmonella
resistant to at least one anti-salmonella antibiotic. Diseased animal
food accounts for 80% of salmonellosis in humans, or 1.4 million cases
per year. The conventional approach to countering this epidemic is to
radiate food to try to kill all organisms while continuing to use the
antibiotics that created the problem in the first place. Approximately
20% of chickens are contaminated with Campylobacter jejuni, an
organism that causes 2.4 million cases of illness annually. Fifty-four
percent of these organisms are resistant to at least one
anti-campylobacter antimicrobial agent.

Denmark banned
growth-promoting antibiotics beginning in 1999, which cut their use by
more than half within a year, from 453,200 to 195,800 pounds. A report
from Scandinavia found that removing antibiotic growth promoters had
no or minimal effect on food production costs. Agger warns that the
current crowded, unsanitary methods of animal farming in the US
support constant stress and infection, and are geared toward high
antibiotic use.

In the US, over 3
million pounds of antibiotics are used every year on humans. With a
population of 284 million Americans, this amount is enough to give
every man, woman, and child 10 teaspoons of pure antibiotics per year.
Agger says that exposure to a steady stream of antibiotics has altered
pathogens such as Streptococcus pneumoniae, Staplococcus
aureus, and entercocci, to name a few.

Almost half of
patients with upper respiratory tract infections in theU.S. still receive antibiotics from their doctor.(51)
According to the CDC, 90% of upper respiratory infections are viral
and should not be treated with antibiotics. In Germany, the prevalence
of systemic antibiotic use in children aged 0-6 years was 42.9%.(52)

Data obtained from
nine US health insurers on antibiotic use in 25,000 children from 1996
to 2000 found that rates of antibiotic use decreased. Antibiotic use
in children aged three months to under 3 years decreased 24%, from
2.46 to 1.89 antibiotic prescriptions per patient per year. For
children aged 3 to under 6 years, there was a 25% reduction from 1.47
to 1.09 antibiotic prescriptions per patient per year. And for
children aged 6 to under 18 years, there was a 16% reduction from 0.85
to 0.69 antibiotic prescriptions per patient per year.(53)
Despite these reductions, the data indicate that on average every
child in America receives 1.22 antibiotic prescriptions annually.

Group A
beta-hemolytic streptococci is the only common cause of sore throat
that requires antibiotics, with penicillin and erythromycin the only
recommended treatment. Ninety percent of sore-throat cases, however,
are viral. Antibiotics were used in 73% of the estimated 6.7 million
adult annual visits for sore throat in the US between 1989 and 1999.
Furthermore, patients treated with antibiotics were prescribed
non-recommended broad-spectrum antibiotics in 68% of visits. This
period saw a significant increase in the use of newer, more expensive
broad-spectrum antibiotics and a decrease in use of the recommended
antibiotics penicillin and erythromycin.(54)
A ntibiotics being prescribed in 73% of sore-throat cases instead of
the recommended 10% resulted in a total of 4.2 million unnecessary
antibiotic prescriptions from 1989 to 1999.

The Problem
with Antibiotics

In September 2003,
the CDC re-launched a program started in 1995 called “Get Smart: Know
When Antibiotics Work.”(55)
This $1.6 million campaign is designed to educate patients about the
overuse and inappropriate use of antibiotics. Most people involved
with alternative medicine have known about the dangers of antibiotic
overuse for decades. Finally the government is focusing on the
problem, yet it is spending only a miniscule amount of money on an
iatrogenic epidemic that is costing billions of dollars and thousands
of lives. The CDC warns that 90% of upper respiratory infections,
including children's ear infections, are viral and that antibiotics do
not treat viral infection. More than 40% of about 50 million
prescriptions for antibiotics written each year in physicians' offices
are inappropriate.(2)
U sing antibiotics when not needed can lead to the development of
deadly strains of bacteria that are resistant to drugs and cause more
than 88,000 deaths due to hospital-acquired infections.(9)
The CDC, however, seems to be blaming patients for misusing
antibiotics even though they are available only by prescription from
physicians. According to Dr. Richard Besser, head of “Get Smart”:
"Programs that have just targeted physicians have not worked.
Direct-to-consumer advertising of drugs is to blame in some cases.”
Besser says the program “teaches patients and the general public that
antibiotics are precious resources that must be used correctly if we
want to have them around when we need them. Hopefully, as a result of
this campaign, patients will feel more comfortable asking their
doctors for the best care for their illnesses, rather than asking for
antibiotics."(56)

What constitutes
the “best care”? The CDC does not elaborate and ignores the latest
research on the dozens of nutraceuticals that have been scientifically
proven to treat viral infections and boost immune-system function.
Will doctors recommend vitamin C, echinacea, elderberry, vitamin A,
zinc, or homeopathic oscillococcinum? Probably not. The CDC's
common-sense recommendations that most people follow anyway include
getting proper rest, drinking plenty of fluids, and using a
humidifier.

The pharmaceutical
industry claims it supports limiting the use of antibiotics. The drug
company Bayer sponsors a program called “Operation Clean Hands”
through an organization called LIBRA.(57)
The CDC also is involved in trying to minimize antibiotic resistance,
but nowhere in its publications is there any reference to the role of
nutraceuticals in boosting the immune system, nor to the thousands of
journal articles that support this approach. This tunnel vision and
refusal to recommend the available non-drug alternatives is
unfortunate when the CDC is desperately trying to curb the overuse of
antibiotics.

Drugs Pollute
Our Water Supply

We have reached
the point of saturation with prescription drugs. Every body of water
tested contains measurable drug residues. The tons of antibiotics used
in animal farming, which run off into the water table and surrounding
bodies of water, are conferring antibiotic resistance to germs in
sewage, and these germs also are found in our water supply. Flushed
down our toilets are tons of drugs and drug metabolites that also find
their way into our water supply. We have no way to know the long-term
health consequences of ingesting a mixture of drugs and drug-breakdown
products. These drugs represent another level of iatrogenic disease
that we are unable to completely measure.(58-67)

Specific Drug
Iatrogenesis: NSAIDs

It's not just the
US that is plagued by iatrogenesis. A survey of more than 1,000 French
general practitioners (GPs) tested their basic pharmacological
knowledge and practice in prescribing NSAIDs, which rank first among
commonly prescribed drugs for serious adverse reactions. The study
results suggest that GPs do not have adequate knowledge of these drugs
and are unable to effectively manage adverse reactions.(68)

A cross-sectional
survey of 125 patients attending specialty pain clinics in South
London found that possible iatrogenic factors such as
“over-investigation, inappropriate information, and advice given to
patients as well as misdiagnosis, over-treatment, and inappropriate
prescription of medication were common.”(69)

Specific Drug
Iatrogenesis: Cancer Chemotherapy

In 1989, German
biostatistician Ulrich Abel, PhD, wrote a monograph entitled
“Chemotherapy of Advanced Epithelial Cancer.” It was later published
in shorter form in a peer-reviewed medical journal.(70)
Abel presented a comprehensive analysis of clinical trials and
publications representing over 3,000 articles examining the value of
cytotoxic chemotherapy on advanced epithelial cancer. Epithelial
cancer is the type of cancer with which we are most familiar, arising
from epithelium found in the lining of body organs such as the breast,
prostate, lung, stomach, and bowel. From these sites, cancer usually
infiltrates adjacent tissue and spreads to the bone, liver, lung, or
brain. With his exhaustive review, Abel concluded there is no direct
evidence that chemotherapy prolongs survival in patients with advanced
carcinoma; in small-cell lung cancer and perhaps ovarian cancer, the
therapeutic benefit is only slight. According to Abel, “Many
oncologists take it for granted that response to therapy prolongs
survival, an opinion which is based on a fallacy and which is not
supported by clinical studies.”

Over a decade
after Abel's exhaustive review of chemotherapy, there seems no
decrease in its use for advanced carcinoma. For example, when
conventional chemotherapy and radiation have not worked to prevent
metastases in breast cancer, high-dose chemotherapy (HDC) along with
stem-cell transplant (SCT) is the treatment of choice. In March 2000,
however, results from the largest multi-center randomized controlled
trial conducted thus far showed that, compared to a prolonged course
of monthly conventional-dose chemotherapy, HDC and SCT were of no
benefit, (71)
with even a slightly lower survival rate for the HDC/SCT group.
Serious adverse effects occurred more often in the HDC group than the
standard-dose group. One treatment-related death (within 100 days of
therapy) was recorded in the HDC group, but none was recorded in the
conventional chemotherapy group. The women in this trial were highly
selected as having the best chance to respond.

Unfortunately, no
all-encompassing follow-up study such as Dr. Abel's exists to indicate
whether there has been any improvement in cancer-survival statistics
since 1989. In fact, research should be conducted to determine whether
chemotherapy itself is responsible for secondary cancers instead of
progression of the original disease. We continue to question why
well-researched alternative cancer treatments are not used.

Drug Companies
Fined

Periodically, the
FDA fines a drug manufacturer when its abuses are too glaring and
impossible to cover up. In May 2002, The Washington Post
reported that Schering-Plough Corp., the maker of Claritin, was to pay
a $500 million dollar fine to the FDA for quality-control problems at
four of its factories.(72)
The indictment came after the Public Citizen Health Research Group,
led by Dr. Sidney Wolfe, called for a criminal investigation of
Schering-Plough, charging that the company distributed albuterol
asthma inhalers even though it knew the units were missing the active
ingredient.

The FDA tabulated
infractions involving 125 products, or 90% of the drugs made by
Schering-Plough since 1998. Besides paying the fine, the company was
forced to halt the manufacture of 73 drugs or suffer another $175
million fine. Schering-Plough's news releases told another story,
assuring consumers that they should still feel confident in the
company's products.

This large
settlement served as a warning to the drug industry about maintaining
strict manufacturing practices and has given the FDA more clout in
dealing with drug company compliance. According to The Washington
Post article, a federal appeals court ruled in 1999 that the FDA
could seize the profits of companies that violate "good manufacturing
practices." Since that time, Abbott Laboratories has paid a $100
million fine for failing to meet quality standards in the production
of medical test kits, while Wyeth Laboratories paid $30 million in
2000 to settle accusations of poor manufacturing practices.

UNNECESSARY
SURGICAL PROCEDURES

In 1974, 2.4
million unnecessary surgeries were performed, resulting in 11,900
deaths at a cost of $3.9 billion.(73,74)
In 2001, 7.5 million unnecessary surgical procedures were performed,
resulting in 37,136 deaths at a cost of $122 billion (using 1974
dollars).(3)

It is very
difficult to obtain accurate statistics when studying unnecessary
surgery. In 1989, Leape wrote that perhaps 30% of controversial
surgeries—which include cesarean section, tonsillectomy, appendectomy,
hysterectomy, gastrectomy for obesity, breast implants, and elective
breast implants(74)—
are unnecessary. In 1974, the Congressional Committee on Interstate
and Foreign Commerce held hearings on unnecessary surgery. It found
that 17.6% of recommendations for surgery were not confirmed by a
second opinion. The House Subcommittee on Oversight and Investigations
extrapolated these figures and estimated that, on a nationwide basis,
there were 2.4 million unnecessary surgeries performed annually,
resulting in 11,900 deaths at an annual cost of $3.9 billion.(73)

According to the
Healthcare Cost and Utilization Project within the Agency for
Healthcare Research and Quality(13),
in 2001 the 50 most common medical and surgical procedures were
performed approximately 41.8 million times in the US. Using the 1974
House Subcommittee on Oversight and Investigations' figure of 17.6% as
the percentage of unnecessary surgical procedures, and extrapolating
from the death rate in 1974, produces nearly 7.5 million (7,489,718)
unnecessary procedures and a death rate of 37,136, at a cost of $122
billion (using 1974 dollars).

In 1995,
researchers conducted a similar analysis of back surgery procedures,
using the 1974 “unnecessary surgery percentage” of 17.6. Testifying
before the Department of Veterans Affairs, they estimated that of the
250,000 back surgeries performed annually in the US at a hospital cost
of $11,000 per patient, the total number of unnecessary back surgeries
approaches 44,000, costing as much as $484 million.(75)

Like prescription
drug use driven by television advertising, unnecessary surgeries are
escalating. Media-driven surgery such as gastric bypass for obesity
“modeled” by Hollywood celebrities seduces obese people to think this route is safe and sexy.
Unnecessary surgeries have even been marketed on the Internet.(76)
A study in Spain declares that 20-25% of total surgical practice
represents unnecessary operations.(77)

According to data
from the National Center for Health Statistics for 1979 to 1984, the
total number of surgical procedures increased 9% while the number of
surgeons grew 20%. The study notes that the large increase in the
number of surgeons was not accompanied by a parallel increase in the
number of surgeries performed, and expressed concern about an excess
of surgeons to handle the surgical caseload.(78)

From 1983 to 1994,
however, the incidence of the 10 most commonly performed surgical
procedures jumped 38%, to 7,929,000 from 5,731,000 cases. By 1994,
cataract surgery was the most common procedure with more than 2
million operations, followed by cesarean section (858,000 procedures)
and inguinal hernia operations (689,000 procedures). Knee arthroscopy
procedures increased 153% while prostate surgery declined 29%.(79)

The list of
iatrogenic complications from surgery is as long as the list of
procedures themselves. One study examined catheters that were inserted
to deliver anesthetic into the epidural space around the spinal nerves
for lower cesarean section, abdominal surgery, or prostate surgery. In
some cases, non-sterile technique during catheter insertion resulted
in serious infections, even leading to limb paralysis.(80)

In one review of
the literature, the authors found “a significant rate of
overutilization of coronary angiography, coronary artery surgery,
cardiac pacemaker insertion, upper gastrointestinal endoscopies,
carotid endarterectomies, back surgery, and pain-relieving
procedures.”(81)

A 1987 JAMA
study found the following significant levels of inappropriate surgery:
17% of coronary angiography procedures, 32% of carotid endarterectomy
procedures, and 17% of upper gastrointestinal tract endoscopy
procedures.(82)
Based on the Healthcare Cost and Utilization Project (HCUP) statistics
provided by the government for 2001, 697,675 upper gastrointestinal
endoscopies (usually entailing biopsy) were performed, as were 142,401
endarterectomies and 719,949 coronary angiographies.(13)
Extrapolating the JAMA study's inappropriate surgery rates to
2001 produces 118,604 unnecessary endoscopy procedures, 45,568
unnecessary endarterectomies, and 122,391 unnecessary coronary
angiographies. These are all forms of medical iatrogenesis.

MEDICAL AND SURGICAL PROCEDURES

It is instructive
to know the mortality rates associated with various medical and
surgical procedures. Although we must sign release forms when we
undergo any procedure, many of us are in denial about the true risks
involved; because medical and surgical procedures are so commonplace,
they often are seen as both necessary and safe. Unfortunately,
allopathic medicine itself is a leading cause of death, as well as the
most expensive way to die.

Perhaps the words
“health care” confer the illusion that medicine is about health.
Allopathic medicine is not a purveyor of health care but of disease
care. The HCUP figures are instructive,(13)
but the computer program that calculates annual mortality statistics
for all US hospital discharges is only as good as the codes entered
into the system. In email correspondence, HCUP indicated that the
mortality rates for each procedure indicated only that someone
undergoing that procedure died either from the procedure or from some
other cause.

Thus there is no
way of knowing exactly how many people die from a particular
procedure. While codes for “poisoning & toxic effects of drugs” and
“complications of treatment” do exist, the mortality figures
registered in these categories are very low and do not correlate with
what is known from research such as the 1998 JAMA study(1)
that estimated an average of 106,000 prescription medication deaths
per year. No codes exist for adverse drug side effects, surgical
mishaps, or other types of medical error. Until such codes exist, the
true mortality rates tied to of medical error will remain buried in
the general statistics.

AN HONEST LOOK
AT US HEALTH CARE

In 1978, the US
Office of Technology Assessment (OTA) reported: “Only 10-20% of all
procedures currently used in medical practice have been shown to be
efficacious by controlled trial."(83)
In 1995, the OTA compared medical technology in eight countries (
Australia , Canada, France, Germany, the Netherlands, Sweden, the UK,
and the US ) and again noted that few medical procedures in the US
have been subjected to clinical trial. It also reported that US infant mortality was high and life expectancy low compared to other
developed countries.(84)

Although almost 10
years old, much of what was written in the OTA report holds true
today. The report blames the high cost of American medicine on the
medical free-enterprise system and failure to create a national health
care policy. It attributes the government's failure to control health
care costs to market incentives and profit motives inherent in the
current financing and organization of health care, which includes such
interests as private health insurers, hospital systems, physicians,
and the drug and medical-device industries. “Health Care Technology
and Its Assessment in Eight Countries” is the last report prepared by
the OTA, which was disbanded in 1995. It also is perhaps the US
government's last honest, detailed examination of the nation's health
care system. An appendix summarizing this 60-page report follows this
article.

SURGICAL ERRORS FINALLY REPORTED

An October 2003
JAMA study from the US government's Agency for Healthcare Research
and Quality (AHRQ) documented 32,000 mostly surgery-related deaths
costing $9 billion and accounting for 2.4 million extra hospital days
in 2000.(85)
Data from 20% of the nation's hospitals were analyzed for 18 different
surgical complications, including postoperative infections, foreign
objects left in wounds, surgical wounds reopening, and post-operative
bleeding.

In a press release
accompanying the study, AHRQ director Carolyn M. Clancy, MD, noted:
“This study gives us the first direct evidence that medical injuries
pose a real threat to the American public and increase the costs of
health care.”(86)
According to the study's authors, “The findings greatly underestimate
the problem, since many other complications happen that are not listed
in hospital administrative data.” They added: "The message here is
that medical injuries can have a devastating impact on the health care
system. We need more research to identify why these injuries occur and
find ways to prevent them from happening." The study authors said that
improved medical practices, including an emphasis on better hand
washing, might help reduce morbidity and mortality rates. In an
accompanying JAMA editorial, health-risk researcher Dr. Saul
Weingart of Harvard's Beth Israel-Deaconess Medical Center wrote,
“Given their staggering magnitude, these estimates are clearly
sobering.”(87)

UNNECESSARY
X-RAYS

When x-rays were
discovered, no one knew the long-term effects of ionizing radiation.
In the 1950s, monthly fluoroscopic exams at the doctor's office were
routine, and you could even walk into most shoe stores and see x-rays
of your foot bones. We still do not know the ultimate outcome of our
initial fascination with x-rays.

In those days, it
was common practice to x-ray pregnant women to measure their pelvises
and make a diagnosis of twins. Finally, a study of 700,000 children
born between 1947 and 1964 in 37 major maternity hospitals compared
the children of mothers who had received pelvic x-rays during
pregnancy to those of mothers who did not. It found that cancer
mortality was 40% higher among children whose mothers had been
x-rayed.(88)

In present-day
medicine, coronary angiography is an invasive surgical procedure that
involves snaking a tube through a blood vessel in the groin up to the
heart. To obtain useful information, X-rays are taken almost
continuously, with minimum dosages ranging from 460 to 1,580 mrem. The
minimum radiation from a routine chest x-ray is 2 mrem. X-ray
radiation accumulates in the body, and ionizing radiation used in
X-ray procedures has been shown to cause gene mutation. The health
impact of this high level of radiation is unknown, and often obscured
in statistical jargon such as, “The risk for lifetime fatal cancer due
to radiation exposure is estimated to be 4 in one million per 1,000
mrem.”(89)

Dr. John Gofman
has studied the effects of radiation on human health for 45 years. A
medical doctor with a PhD in nuclear and physical chemistry, Gofman
worked on the Manhattan Project, discovered uranium-233, and was the
first person to isolate plutonium. In five scientifically documented
books, Gofman provides strong evidence that medical
technology—specifically x-rays, CT scans, and mammography and
fluoroscopy devices—are a contributing factor to 75% of new cancers.
In a nearly 700-page report updated in 2000, “Radiation from Medical
Procedures in the Pathogenesis of Cancer and Ischemic Heart Disease:
Dose-Response Studies with Physicians per 100,000 Population,”(90)
Gofman shows that as the number of physicians increases in a
geographical area along with an increase in the number of x-ray
diagnostic tests performed, the rate of cancer and ischemic heart
disease also increases. Gofman elaborates that it is not x-rays alone
that cause the damage but a combination of health risk factors that
include poor diet, smoking, abortions, and the use of birth control
pills. Dr. Gofman predicts that ionizing radiation will be responsible
for 100 million premature deaths over the next decade.

In his book,
“Preventing Breast Cancer,” Dr. Gofman notes that breast cancer is the
leading cause of death among American women between the ages of 44 and
55. Because breast tissue is highly sensitive to radiation, mammograms
can cause cancer. The danger can be heightened other factors including
a woman's genetic makeup, preexisting benign breast disease,
artificial menopause, obesity, and hormonal imbalance.(91)

Even x-rays for
back pain can lead someone into crippling surgery. Dr. John E. Sarno,
a well-known New York orthopedic surgeon, found that there is not
necessarily any association between back pain and spinal x-ray
abnormality. He cites studies of normal people without a trace of back
pain whose x-rays indicate spinal abnormalities and of people with
back pain whose spines appear to be normal on x-ray.(92)
People who happen to have back pain and show an abnormality on x-ray
may be treated surgically, sometimes with no change in back pain,
worsening of back pain, or even permanent disability. Moreover,
doctors often order x-rays as protection against malpractice claims,
to give the impression of leaving no stone unturned. It appears that
doctors are putting their own fears before the interests of their
patients.

UNNECESSARY
HOSPITALIZATION

Nearly 9 million
(8,925,033) people were hospitalized unnecessarily in 2001.(4)
In a study of inappropriate hospitalization, two doctors reviewed
1,132 medical records. They concluded that 23% of all admissions were
inappropriate and an additional 17% could have been handled in
outpatient clinics. Thirty-four percent of all hospital days were
deemed inappropriate and could have been avoided.(93)
The rate of inappropriate hospital admissions in 1990 was 23.5%.(94)
In 1999, another study also found an inappropriate admissions rate of
24%, indicating a consistent pattern from 1986 to 1999.(95)
The HCUP database indicates that the total number of patient
discharges from US hospitals in 2001 was 37,187,641,(13)
meaning that almost 9 million people were exposed to unnecessary
medical intervention in hospitals and therefore represent almost 9
million potential iatrogenic episodes.(4)

WOMEN'S
EXPERIENCE IN MEDICINE

Dr. Martin Charcot
(1825-1893) was world-renowned, the most celebrated doctor of his
time. He practiced in the Paris hospital La Salpetriere. He became an
expert in hysteria, diagnosing an average of 10 hysterical women each
day, transforming them into “iatrogenic monsters” and turning simple
“neurosis” into hysteria.(96)
The number of women diagnosed with hysteria and hospitalized rose from
1% in 1841 to 17% in 1883. Hysteria is derived from the Latin
“hystera” meaning uterus. According to Dr. Adriane Fugh-Berman, US
medicine has a tradition of excessive medical and surgical
interventions on women. Only 100 years ago, male doctors believed that
female psychological imbalance originated in the uterus. When surgery
to remove the uterus was perfected, it became the “cure” for mental
instability, effecting a physical and psychological castration. Fugh-Berman
notes that US doctors eventually disabused themselves of that notion
but have continued to treat women very differently than they treat
men.(97)
She cites the following statistics:

Thousands of
prophylactic mastectomies are performed annually.

One-third of US
women have had a hysterectomy before menopause.

Women are
prescribed drugs more frequently than are men.

Women are given
potent drugs for disease prevention, which results in disease
substitution due to side effects.

Fetal monitoring is unsupported by studies and not recommended by
the CDC.(98)
It confines women to a hospital bed and may result in a higher
incidence of cesarean section.(99)

Normal
processes such as menopause and childbirth have been heavily “medicalized.”

As many as
one-third of postmenopausal women use HRT.(101,102)
This number is important in light of the much-publicized Women's
Health Initiative Study, which was halted before its completion
because of a higher death rate in the synthetic estrogen-progestin (HRT)
group.(103)

Cesarean
Section

In 1983, 809,000
cesarean sections (21% of live births) were performed in the US,
making it the nation's most common obstetric-gynecologic (OB/GYN)
surgical procedure. The second most common OB/GYN operation was
hysterectomy (673,000), followed by diagnostic dilation and curettage
of the uterus (632,000). In 1983, OB/GYN procedures represented 23% of
all surgery completed in the US.(104)

In 2001, cesarean
section is still the most common OB/GYN surgical procedure.
Approximately 4 million births occur annually, with 24% (960,000)
delivered by cesarean section. In the Netherlands, only 8% of births
are delivered by cesarean section. This suggests 640,000 unnecessary
cesarean sections—entailing three to four times higher mortality and
20 times greater morbidity than vaginal delivery(105)—are
performed annually in the US.

The US cesarean
rate rose from just 4.5% in 1965 to 24.1% in 1986. Sakala contends
that an “uncontrolled pandemic of medically unnecessary cesarean
births is occurring.”(106)
VanHam reported a cesarean section postpartum hemorrhage rate of 7%, a
hematoma formation rate of 3.5%, a urinary tract infection rate of 3%,
and a combined postoperative morbidity rate of 35.7% in a high-risk
population undergoing cesarean section.(107)

NEVER ENOUGH STUDIES

Scientists claimed
there were never enough studies revealing the dangers of DDT and other
dangerous pesticides to ban them. They also used this argument for
tobacco, claiming that more studies were needed before they could be
certain that tobacco really caused lung cancer. Even the American
Medical Association (AMA) was complicit in suppressing the results of
tobacco research. In 1964, when the Surgeon General's report condemned
smoking, the AMA refused to endorse it, claiming a need for more
research. What they really wanted was more money, which they received
from a consortium of tobacco companies that paid the AMA $18 million
over the next nine years during which the AMA said nothing about the
dangers of smoking.(108)

The Journal of
the American Medical Association (JAMA), "after careful
consideration of the extent to which cigarettes were used by
physicians in practice," began accepting tobacco advertisements and
money in 1933. State journals such as the New York State Journal of
Medicine also began to run advertisements for Chesterfield
cigarettes that claimed cigarettes are "Just as pure as the water you
drink… and practically untouched by human hands." In 1948, JAMA
argued "more can be said in behalf of smoking as a form of escape from
tension than against it… there does not seem to be any preponderance
of evidence that would indicate the abolition of the use of tobacco as
a substance contrary to the public health."(109)
Today, scientists continue to use the excuse that more studies are
needed before they will support restricting the inordinate use of
drugs.

ADVERSE DRUG REACTIONS

The Lazarou study(1)
analyzed records for prescribed medications for 33 million US hospital
admissions in 1994. It discovered 2.2 million serious injuries due to
prescribed drugs; 2.1% of inpatients experienced a serious adverse
drug reaction, 4.7% of all hospital admissions were due to a serious
adverse drug reaction, and fatal adverse drug reactions occurred in
0.19% of inpatients and 0.13% of admissions. The authors estimated
that 106,000 deaths occur annually due to adverse drug reactions.

Using a cost
analysis from a 2000 study in which the increase in hospitalization
costs per patient suffering an adverse drug reaction was $5,483, costs
for the Lazarou study's 2.2 million patients with serious drug
reactions amounted to $12 billion.(1,49)

Serious adverse
drug reactions commonly emerge after FDA approval of the drugs
involved. The safety of new agents cannot be known with certainty
until a drug has been on the market for many years.(110)

BEDSORES

Over one million
people develop bedsores in U.S. hospitals every year. It's a
tremendous burden to patients and family, and a $55 billion dollar
healthcare burden.(7)
Bedsores are preventable with proper nursing care. It is true that 50%
of those affected are in a vulnerable age group of over 70. In the
elderly bedsores carry a fourfold increase in the rate of death. The
mortality rate in hospitals for patients with bedsores is between 23%
and 37%. (8)
Even if we just take the 50% of people over 70 with bedsores and the
lowest mortality at 23%, that gives us a death rate due to bedsores of
115,000. Critics will say that it was the disease or advanced age that
killed the patient, not the bedsore, but our argument is that an early
death, by denying proper care, deserves to be counted. It is only
after counting these unnecessary deaths that we can then turn our
attention to fixing the problem.

MALNUTRITION IN NURSING HOMES

The General
Accounting Office (GAO),
a special investigative branch of Congress, cited 20% of the nation's
17,000 nursing homes for violations between July 2000 and January
2002. Many violations involved serious physical injury and death.(111)

A report from the
Coalition for Nursing Home Reform states that at least one-third of
the nation's 1.6 million nursing home residents may suffer from
malnutrition and dehydration, which hastens their death. The report
calls for adequate nursing staff to help feed patients who are not
able to manage a food tray by themselves.(11)
It is difficult to place a mortality rate on malnutrition and
dehydration. The Coalition report states that malnourished residents,
compared with well-nourished hospitalized nursing home residents, have
a fivefold increase in mortality when they are admitted to a hospital.
Multiplying the one-third of 1.6 million nursing home residents who
are malnourished by a mortality rate of 20%(8,14)
results in 108,800 premature deaths due to malnutrition in nursing
homes.

Nosocomial
Infections

The rate of
nosocomial infections per 1,000 patient days rose from 7.2 in 1975 to
9.8 in 1995, a 36% jump in 20 years. Reports from more than 270
US hospitals showed that the nosocomial infection rate itself had remained
stable over the previous 20 years, with approximately five to six
hospital-acquired infections occurring per 100 admissions, a rate of
5-6%. Due to progressively shorter inpatient stays and the increasing
number of admissions, however, the number of infections increased. It
is estimated that in 1995, nosocomial infections cost $4.5 billion and
contributed to more than 88,000 deaths, or one death every 6 minutes.(9)
The 2003 incidence of nosocomial mortality is quite probably higher
than in 1995 because of the tremendous increase in
antibiotic-resistant organisms. Morbidity and Mortality Report found
that nosocomial infections cost $5 billion annually in 1999,(10)
representing a $0.5 billion increase in just four years. At this rate
of increase, the current cost of nosocomial infections would be around
$5.5 billion.

Outpatient Iatrogenesis

In a 2000 JAMA
article, Dr. Barbara Starfield presents well-documented facts that
are both shocking and unassailable.(12)
The U.S. ranks 12th of 13 industrialized countries when judged by 16
health status indicators. Japan, Sweden, and Canada were first,
second, and third, respectively. More than 40 million people in the US
have no health insurance, and 20-30% of patients receive
contraindicated care.

Starfield warns
that one cause of medical mistakes is overuse of technology, which may
create a "cascade effect" leading to still more treatment. She urges
the use of ICD (International Classification of Diseases) codes that
have designations such as "Drugs, Medicinal, and Biological Substances
Causing Adverse Effects in Therapeutic Use" and "Complications of
Surgical and Medical Care" to help doctors quantify and recognize the
magnitude of the medical error problem. Starfield notes that many
deaths attributable to medical error today are likely to be coded to
indicate some other cause of death. She concludes that against the
backdrop of our poor health report card compared to other Westernized
countries, we should recognize that the harmful effects of health care
interventions account for a substantial proportion of our excess
deaths.

Starfield cites
Weingart's 2000 article, “Epidemiology of Medical Error,” as well as
other authors to suggest that between 4% and 18% of consecutive
patients in outpatient settings suffer an iatrogenic event leading to:

116 million
extra physician visits

77 million
extra prescriptions filled

17 million
emergency department visits

8 million
hospitalizations

3 million
long-term admissions

199,000
additional deaths

$77 billion in
extra costs(112)

Unnecessary Surgeries

While some 12,000
deaths occur each year from unnecessary surgeries, results from the
few studies that have measured unnecessary surgery directly indicate
that for some highly controversial operations, the proportion of
unwarranted surgeries could be as high as 30%.(74)

MEDICAL ERRORS:
A GLOBAL ISSUE

A five-country
survey published in the Journal of Health Affairs found that
18-28% of people who were recently ill had suffered from a medical or
drug error in the previous two years. The study surveyed 750 recently
ill adults. The breakdown by country showed the percentages of those
suffering a medical or drug error were 18% in Britain, 23% in
Australia and in New Zealand, 25% in Canada, and 28% in the US.(113)

HEALTH INSURANCE

The Institute of
Medicine recently found that the 41 million Americans with no health
insurance have consistently worse clinical outcomes than those who are
insured, and are at increased risk for dying prematurely.(114).

When doctors bill
for services they do not render, advise unnecessary tests, or screen
everyone for a rare condition, they are committing insurance fraud.
The US GAO estimated that $12 billion dollars was lost to fraudulent
or unnecessary claims in 1998, and reclaimed $480 million in judgments
in that year. In 2001, the federal government won or negotiated more
than $1.7 billion in judgments, settlements, and administrative
impositions in health care fraud cases and proceedings.(115)

WAREHOUSING OUR
ELDERS

One way to measure
the moral and ethical fiber of a society is by how it treats its
weakest and most vulnerable members. In some cultures, elderly people
lives out their lives in extended family settings that enable them to
continue participating in family and community affairs. American
nursing homes, where millions of our elders go to live out their final
days, represent the pinnacle of social isolation and medical abuse.

In America,
approximately 1.6 million elderly are confined to nursing homes. By
2050, that number could be 6.6 million.(11,116)

Twenty percent
of all deaths from all causes occur in nursing homes.(117)

Hip fractures
are the single greatest reason for nursing home admissions.(118)

Nursing homes
represent a reservoir for drug-resistant organisms due to overuse of
antibiotics.(119)

Presenting a
report he sponsored entitled "Abuse of Residents is a Major Problem in
U.S. Nursing Homes" on July 30, 2001, Rep. Henry Waxman (D-CA)
noted that “as a society we will be judged by how we treat the
elderly." The report found one-third of the nation's approximately
17,000 nursing homes were cited for an abuse violation in a two-year
period from January 1999 to January 2001.(116)
According to Waxman, “the people who cared for us deserve better." The
report suggests that this known abuse represents only the “tip of the
iceberg” and that much more abuse occurs that we aware of or ignore.(116a)
The report found:

Over 30% of US
nursing homes were cited for abuses, totaling more than 9,000
violations.

10% of nursing
homes had violations that caused actual physical harm to residents
or worse.

Over 40%(3,800)
of the abuse violations followed the filing of a formal complaint,
usually by concerned family members.

Dangerously
understaffed nursing homes lead to neglect, abuse, overuse of
medications, and physical restraints. In 1990, Congress mandated an
exhaustive study of nurse-to-patient ratios in nursing homes. The
study was finally begun in 1998 and took four years to complete.(120)
A spokesperson for The National Citizens' Coalition for Nursing Home
Reform commented on the study: “They compiled two reports of three
volumes each thoroughly documenting the number of hours of care
residents must receive from nurses and nursing assistants to avoid
painful, even dangerous, conditions such as bedsores and infections.
Yet it took the Department of Health and Human Services and Secretary
Tommy Thompson only four months to dismiss the report as
‘insufficient.'”(121)
Although preventable with proper nursing care, bedsores occur three
times more commonly in nursing homes than in acute care or veterans
hospitals.(122).

Because many
nursing home patients suffer from chronic debilitating conditions,
their assumed cause of death often is unquestioned by physicians. Some
studies show that as many as 50% of deaths due to restraints, falls,
suicide, homicide, and choking in nursing homes may be covered up.(123,124)
It is possible that many nursing home deaths are instead attributed to
heart disease. In fact, researchers have found that heart disease may
be over-represented in the general population as a cause of death on
death certificates by 8-24%. In the elderly, the overreporting of
heart disease as a cause of death is as much as twofold.(125)

That very few
statistics exist concerning malnutrition in acute-care hospitals and
nursing homes demonstrates the lack of concern in this area. While a
survey of the literature turns up few US studies, one revealing US
study evaluated the nutritional status of 837 patients in a 100-bed
subacute-care hospital over a 14-month period. The study found only 8%
of the patients were well nourished, while 29% were malnourished and
63% were at risk of malnutrition. As a result, 25% of the malnourished
patients required readmission to an acute-care hospital, compared to
11% of the well-nourished patients. The authors concluded that
malnutrition reached epidemic proportions in patients admitted to this
subacute-care facility.(126)

Many studies
conclude that physical restraints are an underreported and preventable
cause of death. Studies show that compared to no restraints, the use
of restraints carries a higher mortality rate and economic burden.(127-129)
Studies have found that physical restraints, including bedrails, are
the cause of at least 1 in every 1,000 nursing-home deaths.(130-132)

Deaths caused by
malnutrition, dehydration, and physical restraints, however, are
rarely recorded on death certificates. Several studies reveal that
nearly half of the listed causes of death on death certificates for
elderly people with chronic or multi-system disease are inaccurate.(133)
Even though 1 in 5 people die in nursing homes, an autopsy is
performed in less than 1% of these deaths.(134).

Overmedicating
Seniors

Dr. Robert
Epstein, chief medical officer of Medco Health Solutions Inc. (a unit
of Merck & Co.), conducted a study in 2003 of drug trends among the
elderly.(135)
He found that seniors are going to multiple physicians, getting
multiple prescriptions, and using multiple pharmacies. Medco oversees
drug-benefit plans for more than 60 million Americans, including 6.3
million seniors who received more than 160 million prescriptions.
According to the study, the average senior receives 25 prescriptions
each year. Among those 6.3 million seniors, a total of 7.9 million
medication alerts were triggered: less than one-half that number, 3.4
million, were detected in 1999. About 2.2 million of those alerts
indicated excessive dosages unsuitable for seniors, and about 2.4
million alerts indicated clinically inappropriate drugs for the
elderly. Reuters interviewed Kasey Thompson, director of the Center on
Patient Safety at the American Society of Health System Pharmacists,
who noted: “There are serious and systemic problems with poor
continuity of care in the United States .” He says this study
represents only “the tip of the iceberg” of a national problem.

According to
Drug Benefit Trends , the average number of prescriptions
dispensed per non-Medicare HMO member per year rose 5.6% from 1999 to
2000, - from 7.1 to 7.5 prescriptions. The average number dispensed
for Medicare members increased 5.5%, from 18.1 to 19.1 prescriptions.(136)
The total number of prescriptions written in the US in 2000 was 2.98
billion, or 10.4 prescriptions for every man, woman, and child.(137)

In a study of 818
residents of residential care facilities for the elderly, 94% were
receiving at least one medication at the time of the interview. The
average intake of medications was five per resident; the authors noted
that many of these drugs were given without a documented diagnosis
justifying their use.(138)

Seniors and groups
like the American Association for Retired Persons(AARP)
are demanding that prescription drug coverage be a basic right.(139)
They have accepted allopathic medicine's overriding assumption that
aging and dying in America must be accompanied by drugs in nursing
homes and eventual hospitalization. Seniors are given the choice of
either high-cost patented drugs or low-cost generic drugs. Drug
companies attempt to keep the most expensive drugs on the shelves and
suppress access to generic drugs, despite facing stiff fines of
hundreds of millions of dollars levied by the federal government.(140,141)
In 2001, some of the world's largest drug companies were fined a
record $871 million for conspiring to increase the price of vitamins.(142)

Current AARP
recommendations for diet and nutrition assume that seniors are getting
all the nutrition they need in an average diet. At most, AARP suggests
adding extra calcium and a multivitamin and mineral supplement.(143)

Ironically,
studies also indicate underuse of proper pain medication for patients
who need it. One study evaluated pain management in a group of 13,625
cancer patients, aged 65 and over, living in nursing homes. While
almost 30% of the patients reported pain, more than 25% received no
pain relief medication, 16% received a mild analgesic drug, 32%
received a moderate analgesic drug, and 26% received adequate
pain-relieving morphine. The authors concluded that older patients and
minority patients were more likely to have their pain untreated.(144)

WHAT REMAINS TO BE UNCOVERED

Our ongoing
research will continue to quantify the morbidity, mortality, and
financial loss due to:

* Part of our
ongoing research will be to quantify the mortality and morbidity
caused by hormone replacement therapy (HRT) since the 1940s. In
December 2000, a government scientific advisory panel recommended that
synthetic estrogen be added to the nation's list of cancer-causing
agents. HRT, either synthetic estrogen alone or combined with
synthetic progesterone, is used by an estimated 13.5 to 16 million
women in the US.(145)
The aborted Women's Health Initiative Study (WHI) of 2002 showed that
women taking synthetic estrogen combined with synthetic progesterone
have a higher incidence of ovarian cancer, breast cancer, stroke, and
heart disease, with little evidence of osteoporosis reduction or
dementia prevention. WHI researchers, who usually never make
recommendations except to suggest more studies, advised doctors to be
very cautious about prescribing HRT to their patients.(100,146-150)

Results of the
“Million Women Study” on HRT and breast cancer in the UK were published in medical journal The Lancet in August 2003.
According to lead author Prof. Valerie Beral, director of the Cancer
Research UK Epidemiology Unit: "We estimate that over the past decade,
use of HRT by UK women aged 50-64 has resulted in an extra 20,000
breast cancers, estrogen-progestagen (combination) therapy accounting
for 15,000 of these.”(151)
We were unable to find statistics on breast cancer, stroke, uterine
cancer, or heart disease caused by HRT used by American women. Because
the US population is roughly six times that of the UK, it is possible
that 120,000 cases of breast cancer have been caused by HRT in the
past decade.

OFFICE OF
TECHNOLOGY ASSESSMENT (OTA)

Health Care
Technology and Its Assessment in Eight Countries, 1995.

General Facts

In 1990, US
life expectancy was 71.8 years for men and 78.8 years for women,
among the lowest rates in the developed countries.

The 1990 US
infant mortality rate in the US was 9.2 per 1,000 live births, in
the bottom half of the distribution among all developed countries.

Health status
is correlated with socioeconomic status.

Health care is
not universal

Health care is
based on the free market system with no fixed budget or limitations
on expansion.

Health care
accounts for 14% of the US GNP ($800 billion in 1993).

The federal
government does no central planning, though it is the major
purchaser of health care for older people and some poor people.

Americans are
less satisfied with their health care system than people in other
developed countries.

US medicine
specializes in expensive medical technology; some large US cities
have more magnetic resonance image (MRI) scanners than most
countries.

Huge public and
private investments in medical research and pharmaceutical
development drive this “technological arms race.”

Any efforts to
restrain technological developments in health care are opposed by
policymakers concerned about negative impacts on medical-technology
industries.

In 1990, the
average length of stay for 33 million admissions was 9.2 days. The
bed occupancy rate was 66%. Lengths of stay were shorter and
admission rates lower than other countries.

In 1990, theUS had 615,000 physicians,
or 2.4 per 1,000 population; 33% were primary care (family medicine,
internal medicine, and pediatrics) and 67% were specialists.

In 1991,
government-run health care spending totaled $81 billion.

Total US health
care spending rose to $752 billion in 1991 from $70 billion in 1950.
Spending grew five-fold per capita.

Reasons for
increased healthcare spending include:

The high cost
of defensive medicine, with an escalation in services solely to
avoid malpractice litigation.

US health
care based on defensive medicine costs nearly $45 billion per
year, or about 5% of total health care spending, according to one
source.

The
availability and use of new medical technologies have contributed
the most to increased health care spending, argue many analysts.
These costs are impossible to quantify.

The reasons
government attempts to control health care costs have failed
include:

Market
incentive and profit-motive involvement in the financing and
organization of health care, including private insurers, hospital
systems, physicians, and the drug and medical-device industries.

Expansion is
the goal of free enterprise.

Health-Related Research and Development

The US spends
more than any other country on health-related R&D.

In 1989, the
federal government spent $9.2 billion on R&D, while private industry
spent an additional $9.4 billion.

Total US R&D
expenditures rose 50% from 1983 to 1992.

NIH receives
about half of US government R&D funding.

NIH spent more
on basic research ($4.1 billion in 1989) than for clinical trials of
medical treatments on humans ($519 million in 1989).

Most of the
clinical trials evaluate new treatment protocols for cancer and
complications of AIDS, and do not study existing treatments, even
though their effectiveness is in many cases unknown and
questionable.

In 1990, the
NIH had just begun to do meta-analysis and cost-effectiveness
analysis.

Pharmaceutical and Medical-Device
Industries

About
two-thirds of the industry's $9.4 billion budget went to drug
research; device manufacturers spent the remaining one-third.

In addition to
R&D, the medical industry spent 24% of total sales on promoting
their products and 15% of total sales on development.

Total marketing
expenses in 1990 were over $5 billion.

Many products
provide no benefit over existing products.

Public and
private health care consumers buy these products.

If health care
spending is perceived as a problem, a highly profitable drug
industry exacerbates the problem.

Controlling Health Care Technology

The FDA ensures
the safety and efficacy of drugs, biologics, and medical devices.

The FDA does
not consider costs of therapy.

The FDA does
not consider the effectiveness of a therapy.

The FDA does
not compare a product to currently marketed products

The FDA does
not consider nondrug alternatives for a given clinical problem.

It costs $200
million in development costs to bring a new drug to market.
AIDS-drug interest groups forced new regulations that speed up the
approval process.

Such drugs
should be subject to greater post-marketing surveillance
requirements. As of 1995, these provisions had not yet come into
play.

Many argue that
reductions in the pre-approval testing of drugs open the possibility
of significant undiscovered toxicities.

Health Care Technology Assessment

Failure to
evaluate technology was a focus of a 1978 report from OTA with
examples of many common medical practices supported by limited
published data (10-20%).

In 1978,
Congress created the NationalCenter for Health Care Technology (NCHCT) to advise Medicare and
Medicaid.

With an annual
budget of $4 million, NCHCT published three broad assessments of
high-priority technologies and made about 75 coverage
recommendations to Medicare.

Congress
disbanded NCHCT in 1981. The medical profession opposed it from the
beginning. The AMA testified before Congress in 1981 that “clinical
policy analysis and judgments are better made—and are being
responsibly made—within the medical profession. Assessing risks and
costs, as well as benefits, has been central to the exercise of good
medical judgment for decades.”

The medical
device lobby also opposed government oversight by NCHCT.

Examples of
Lack of Proper Management of HealthCare

Treatments for Coronary Artery Disease

Since the early
1970s, the number of coronary artery bypass surgeries (CABGS) has
risen rapidly without government regulation or clinical trials.

Angioplasty for
single vessel disease was introduced in 1978. The first published
trial of angioplasty versus medical treatment was done in 1992.

Angioplasty did
not reduce the number of CABGS, as was promoted.

Both procedures
increase in number every year as the patient population grows older
and sicker.

Rates of use
are higher in white patients and private insurance patients, and
vary greatly by geographic region, suggesting that use of these
procedures is based on non-clinical factors.

As of 1995, the
NIH consensus program had not assessed CABGS since 1980 and had
never assessed angioplasty.

RAND researchers evaluated CABGS in New York in 1990. They reviewed 1,300
procedures and found 2% were inappropriate, 90% were appropriate,
and 7% were uncertain. For 1,300 angioplasties, 4% were
inappropriate and 38% uncertain. Using RAND methodologies, a panel of British physicians rated twice as many
procedures “inappropriate” as did a US panel rating the same clinical
cases. The New York numbers are in question because New York State limits the number of surgery centers, and the per-capita supply of
cardiac surgeons in New York
is about one-half of the national average.

The estimated
five-year cost is $33,000 for angioplasty and $40,000 for CABGS.
Angioplasty did not lower costs, due to its high failure rates.

Computed Tomography (CT)

The first CT
scanner in the US was installed at the Mayo Clinic in 1973. By 1992,
the number of operational CT scanners in the US had grown to 6,060.
By comparison, in 1993 there were 216 CT units in Canada .

There is little
information available on how CT scans improve or affect patient
outcomes

In some
institutions, up to 90% of scans performed were negative.

Approval by the
FDA was not required for CT scanners, nor was any evidence of safety
or efficacy.

Magnetic Resonance Imaging (MRI)

MRIs were
introduced in Great Britain in 1978 and in the US in 1980. By 1988,
there were 1,230 units and by 1992 between 2,800 and 3,000.

A definitive
review published in 1994 found less than 30 studies of 5,000 that
were prospective comparisons of diagnostic accuracy or therapeutic
choice.

The American College of Physicians
assessed MRI studies and rated 13 of 17 trials as “weak,” i.e.,
lacking data concerning therapeutic impact or patient outcomes.

The OTA
concluded: “It is evident that hospitals, physician-entrepreneurs,
and medical device manufacturers have approached MRI and CT as
commodities with high-profit potential, and decision-making on the
acquisition and use of these procedures has been highly influenced
by this approach. Clinical evaluation, appropriate patient
selection, and matching supply to legitimate demand might be viewed
as secondary forces.”

Laparoscopic Surgery

Laparoscopic
cholecystectomy was introduced at a professional surgical society
meeting in late 1989. By 1992, 85% of all cholecystectomies were
performed laparoscopically.

There was an
associated increase of 30% in the number of cholecystectomies
performed.

Because of the
increased volume of gall bladder operations, their total cost
increased 11.4% between 1988 and 1992, despite a 25.1% drop in the
average cost per surgery.

The mortality
rate for gall bladder surgeries did not decline as a result of the
lower risk because so many more were performed.

When studies
were finally done on completed cases, the results showed that
laparoscopic cholecystectomy was associated with reduced inpatient
duration, decreased pain, and a shorter period of restricted
activity. But rates of bile duct and major vessel injury increased
and it was suggested that these rates were worse for people with
acute cholecystitis. No clinical trials had been done to clarify
this issue.

Patient demand,
fueled by substantial media attention, was a major force in
promoting rapid adoption of these procedures.

The major
manufacturer of laparoscopic equipment produced the video that
introduced the procedure in 1989.

Doctors were
given two-day training seminars before performing the surgery on
patients.

Infant Mortality

In 1990, theUS ranked 24th in infant
mortality of 38 developed countries with a rate of 9.2 deaths per
1,000 live births.

US black infant
mortality is 18.6 per 1,000 live births, compared to 8.8 for whites.

Screening for Breast Cancer

Mammography
screening in women under 50 has always been a subject of debate.

In 1992, the
Canadian National Breast Cancer Study of 50,000 women showed that
mammography had no effect on mortality for women aged 40-50.

The National
Cancer Institute (NCI) refused to change its recommendations on
mammography.

The American
Cancer Society decided to wait for more studies on mammography.

In December
1993, NCI announced that women over 50 should have routine
screenings every one to two years but that younger women would
derive no benefit from mammography.

Summary

The OTA
concluded: “There are no mechanisms in place to limit dissemination of
technologies regardless of their clinical value.”
Shortly after the release of this report, the OTA was disbanded.

The Society of
Actuaries Health Benefit Systems Practice Advancement Committee. The Troubled Healthcare
System in the US .
September 13, 2003 . Available at: http://www.soa.org/sections/troubled_healthcare.pdf.
Accessed December 18, 2003 .

US Department
of Health and Human Services and US Department of Justice. Health
Care Fraud and Abuse Control Program Annual Report for FY 1998.
April 1999. Health Care Fraud and Abuse Control Program Annual
Report for FY 2001. April 2002.

Abuse of
residents is a major problem in U.S. nursing homes [transcript]. CNN
television. July 30, 2001
117 a. Available at: http://www.house.gov/waxman. Accessed December
17, 2003 .

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